BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11767913 · Received May 4, 2021

    Report

    Report Number
    1920898-2021-00512
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE SYRINGE WITH 0.3ML GRADUATION MARKINGS. WHEN ATTEMPTED, WATER COULD NOT BE DRAWN INTO THE SYRINGE. THE SYRINGE WAS INSPECTED UNDER THE MICROSCOPE AND NO DEFECTS WERE IMMEDIATELY VISIBLE. A WIRE WAS THREADED INTO THE DISTAL TIP OF THE CANNULA. THE WIRE REACHED SEVERAL MILLIMETERS INTO THE LENGTH OF THE CANNULA BEFORE STOPPING. THE WIRE COULD NOT BE USED TO DISLODGE THE OBSTRUCTION. THE OBSTRUCTION MAY POTENTIALLY BE ADHESIVE BASED ON ITS LOCATION AND DURABILITY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, BD WAS ABLE TO REPLICATE AND CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SYRINGES NOT DRAWING INSULIN IN ONE OF THE ELEVEN SAMPLES RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WERE UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WOULD NOT DRAW UP INSULIN. FROM PHONE CALL ON 2021-04-06 15:26:07: SPOKE WITH CONSUMER TO GET LOT 0160001. ADDED TO FILE CL RELION PEN OWNER REPORTED, NEEDLE WOULD NOT DRAW INSULIN STATED, 2 SYRINGES WERE AFFECTED".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WERE UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WOULD NOT DRAW UP INSULIN. VERBATIM: FROM PHONE CALL ON 2021-04-06 15:26:07: SPOKE WITH CONSUMER TO GET LOT 0160001. ADDED TO FILE CL RELION PEN OWNER REPORTED, NEEDLE WOULD NOT DRAW INSULIN STATED, 2 SYRINGES WERE AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664296 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1